Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/13/2017 |
| Start Date: | August 1996 |
| End Date: | May 1998 |
Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals
Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to
buprenorphine in order to limit the abuse potential that is commonly associated with
buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone
when given through different routes and at different doses.
buprenorphine in order to limit the abuse potential that is commonly associated with
buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone
when given through different routes and at different doses.
Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and
effective treatment for opioid dependence. However, there is concern that buprenorphine may
be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination
tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this
study is to characterize the effects of buprenorphine/naloxone in opioid-dependent
individuals.
This study will last 10 weeks. Participants will stay in a residential research unit, and
will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions,
participants will be randomly assigned to receive either sublingual tablets, intramuscular
injections, or a placebo. The 15 conditions studied will include: sublingual or
intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg),
0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone
(agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.
effective treatment for opioid dependence. However, there is concern that buprenorphine may
be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination
tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this
study is to characterize the effects of buprenorphine/naloxone in opioid-dependent
individuals.
This study will last 10 weeks. Participants will stay in a residential research unit, and
will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions,
participants will be randomly assigned to receive either sublingual tablets, intramuscular
injections, or a placebo. The 15 conditions studied will include: sublingual or
intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg),
0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone
(agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.
Inclusion Criteria:
- Currently opioid dependent
- In good health, as determined by a pre-participation medical examination
- Seeking and eligible for methadone maintenance or detoxification treatment
Exclusion Criteria:
- Significant medical or psychiatric illness, other than drug dependence
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